A Clinical Study of MIL95 in Advanced Malignancies.

Phase 1

Recruiting

• Conditions: Advanced Malignancies
• Interventions: Drug: Recombinant Humanized Monoclonal Antibody MIL95

• Registration Number: NCT04651348
• Lead Sponsor: Beijing Mabworks Biotech Co., Ltd.

Brief Summary

This study is composed of two stages: Part A initial dose escalation and Part B maintenance dose escalation. Both parts will adopt the classical 3+3 dose escalation design.

The starting dose for phase Ia part A is 0.1 mg/kg QW, followed by 3 dose cohorts (0.3mg/kg QW, 0.8mg/kg QW and 1mg/kg QW). Duration of dose limiting toxicity (DLT) observation is 14 days.

Part B will have 5 dose cohorts(3mg/kg QW, 10mg/kg QW, 20mg/kg QW 30mg/kg QW and 45mg/kg QW). DLT observation period is 28 days. The subject number for each cohort in Part B will be increased to 6 if the subject number enrolled in each cohort is less than 6.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-11
• Study First Submitted QC: 2020-12-02
• Study First Posted: 2020-12-03
• Study Start: 2021-01-04
• Primary Completion: 2022-12-08
• Status Verified: 2024-07
• Study Completion: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

1. Adult patients, >=18 years of age;
2. Diagnosis of Refractory/relapsed lymphomas or solid tumor;
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
4. Life expectancy >=3 months;
5. Sufficient organ and bone marrow function;
6. At least one measurable lesion or evaluable lesion (recist v1.1 or Lugano 2014);
7. Able and willing to provide written informed consent and to comply with the study protocol.

Exclusion Criteria

1. Prior use of any anti-cancer therapy(including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc) within 4 weeks of study start;
2. Previous exposure to any drug targeting CD47 or SIRPα;
3. Major surgery within 4 weeks prior to the first administration or expected to undergo major surgery during the study treatment;
4. Live attenuated vaccine administrated within 4 weeks before the first administration or during the study period;
5. Central nervous system metastasis;
6. History of other primary malignant tumors in 5 years;
7. Evidence of significant, uncontrolled concomitant disease;
8. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA or HCV RNA );
9. Active or suspected autoimmune diseases;
10. Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) while participating in the study; 2) for at least 12 months after discontinuation of all study treatments;
11. Known history of hemolytic anemia;
12. Known severe allergic reaction or/and infusion reaction to monoclonal antibody.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MIL95	Recombinant Humanized Monoclonal Antibody MIL95	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Adverse Events	up to 1year after enrollment	Percentage of Participants with AEs and SAEs assessed by NCI CTCAE v5.0.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics:AUC	up to 1year after enrollment	The area under the curve (AUC) of serum concentration of the drug after the administration
Pharmacokinetics: Cmax	up to 1year after enrollment	Maximum concentration(Cmax) of the drug after administration
Objective response rate (ORR)	up to 1year after enrollment	To evaluate preliminary anti-tumor activity of MIL95 in subjects with advanced malignancies.ORR includes complete remission(CR) and partial remission(PR) assessed by RECIST v1.1 criteria for solid tumors and Lugano2014 criteria for lymphoma.
Duration of response (DoR)	up to 1year after enrollment	DOR is defined as the time from the initial response (CR or PR) to the time of disease progression or death, whichever occurs first.
Progression free survival (PFS)	up to 1year after enrollment	Defined as the time from the first day of study treatment to disease progression or death, whichever occurs first.
Immunogenicity	up to 1year after enrollment	Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity of MIL95.

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, China